Kornimate/medical-research-clean huggingface dataset:
a study of atomoxetine for attention deficit and hyperactive/impulsive behaviour problems in children with asd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the primary purpose of this study is to evaluate the tolerability and effectiveness of atomoxetine in the treatment of attention problems, hyperactivity, and impulsivity in children with asd, and secondarily, to evaluate the possible response to atomoxetine on the core symptoms of asd


Eligibility criteria:
inclusion criteria: * male and female outpatients between the ages of at least 6 years of age and not more than 17 years of age at visit 1 * autistic spectrum disorder (dsm-iv tr) diagnosis of autistic disorder or asperger syndrome or pddnos * clinically significant symptoms of adhd (i.e. inattention, impulsiveness, and hyperactivity) that have been present for at least six months (for subjects older than 8 years, the onset of symptoms must be before the age of 7 years) * medication-free for at least two weeks for all psychotropic medications (four weeks for fluoxetine or depot-neuroleptics) * patients must also be able to swallow capsules exclusion criteria: * patients who weigh less than 20 kg or greater than 60 kg at visit 2 * dsm-iv tr diagnosis of a pervasive developmental disorder other than autistic disorder, pdd-nos, asperger's disorder (e.g. rett's disorder, childhood disintegrative disorder) * patients who have a history of bipolar i or ii disorder, schizophrenia, psychosis * patients who have a current diagnosis of major depression (with or without psychotic features), ptsd * patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control
intravenous iron supplement to prevent postoperative delirium after hip fracture surgery

Conditions: Hip Fractures

Summary: this is a clinical trial to evaluate the effect of intravenous iron supplement with ferinject (ferric carboxymaltose) in preventing postoperative delirium after hip fracture surgery.

we hypothesized that iv iron supplement will (1) decrease postoperative delirium in hip fracture patients and (2) decrease the amount of transfusion and transfusion-related complications.

Eligibility criteria:
inclusion criteria: * femur neck fracture, intertrochanteric fractures * iron deficiency anemia (hb\<12 in women, hb\<13 in men) * iron deficiency (serum ferritin \<100ug/l or transferrin saturation\<20%) * who understands this clinical trial and volunteers and agrees to this trial exclusion criteria: * patient under the age of 65 years * hb\<7 or someone who has acute symptom of anemia(tachycardia, dyspnea, or dizziness) * high energy trauma * preoperative delirium * mmse\<10 * underlying disease which involves cognitive dysfunction (e.g. neurovascular diseases, acute myocardial infarction, pulmonary embolism) * those who are inappropriate to participate in the clinical trial assessed by the investigators
polymorphism and auto-reactive b and t cells subsets in adult's immune thrombocytopenia (itp)

Conditions: Immune Thrombocytopenia

Summary: aims of the study : 1) to determine whether the presence of the v158 allele of fc gammariiia gene is associated with a better outcome of immune thrombocytopenia (itp) in adults and especially with a higher response-rate to rituximab. 2) to analyze the impact of therapy and especially rituximab on some b and t cells autoreactive subsets in the peripheral blood. patients and methods : inclusion criteria : age ≥ 18 years, primary itp defined according to the recent consensual criteria (rodeghiero f et al. blood 2009), active itp defined as an itp with a platelet count \< 50 x 109/l requiring treatment, informed consent. main exclusion criteria : secondary itp. blood samples (serum, plasma, dna) will be collected in every patient at time of inclusion (pre-treatment) and then sequentially at 3, 6 and 12 months after inclusion in patients treated with rituximab or during the remission phase for other treatments for immunological studies. when a marrow analysis is indicated, some marrow specimens will also be collected and studied and if a patient will have to undergo a splenectomy as a standard of care, some spleen specimens will also be collected. fc gamma riiia v/f158 polymorphism will be assessed by means of an allele-specific pcr. the sequential analysis of anti-platelets (anti-gpiibiiia) antibodies producing b cells will be performed by means of flow cytometry and elispot analysis. t cells subsets will be harvested in presence of gpiibiiia immunodominant peptides and and cytokines expression will be measured on supernatants on days 2 and 11 in vitro by using luminex technology in order to characterize and distinguish th1, th2, th17, tfh and tregs subsets. the primary outcome will be the overall response rate 1 year after inclusion defined by a platelet count \> 30 x 109/l with at least a two-fold increase of the initial (pre-treatment) count. for the patients treated with rituximab as a standard of care, based on the overall expected response-rate (40-50%) and based on preliminary data on fcgammariiia v/f158 distribution, the inclusion of 85 patients should be sufficient to show an association of the v158 allele and the response (b risk 20% and a 5%). responders and non responders will be compared by non parametrical tests, a multivariate analysis will be than performed using a logistic regression model. the immunological data b and t cells subsets) obtained in both the responders and the non responders will be compared over time (to, m3, m6 and m12) by non parametrical matched tests.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * primary itp as defined by the internation consensus on terminology (rodeghiero et al. blood 2009) regardless the phase of the disease (newly-diagnosed, persistent of chronic itp) * active itp defined by a platelet count \< 50 x 109/l at time of inclusion with indication for treatment * informed consent exclusion criteria: * secondary itp

Keywords: immune thrombocytopenia fc gamma riiia v/f158 polymorphism rituximab autoreactive b and t cells itp
pre-operative treatment with erythropoietin and iron supplement in cardiac surgery

Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery; Anemia, Iron-Deficiency

Summary: pre-treatment of patients with erythropoietin subcutaneously and iron supplement intravenously, in order to create a clinical pathway to minimize transfusion of red blood cells in a selected group of cardiac patients with an increased risk for blood transfusions in our cardiac surgery program.

blood transfusion is identified as an independent predictor of early mortality after coronary artery bypass grafting operations in addition, female gender, lower body surface area (bsa), low preoperative hemoglobin (hb), previous cardiac surgery, emergency operation and low preoperative creatinin clearance were found to be independent risk factors for receiving red blood cells (rbc) units. we create a clinical pathway to reduce transfusion of red blood cells by pretreating patients with erythropoietin and iron to determine the reduction of number of patients who receive blood transfusion perioperatively. also we want to investigate the decrease in the mean number of rbc units received per patient in the perioperative period.

Eligibility criteria:
inclusion criteria: 1. undergoing isolated coronary artery bypass grafting operation or aortic valve repair (avr). 2. preoperative hb \< 7 mmol/l. exclusion criteria: 1. off pump surgery. 2. combination surgery. 3. re-operation. 4. emergency operation. 5. patients with bleeding disturbances; e.g, hemophilia and patients with chronic liver disease. 6. concomitant use of cyclosporine prior to, during or following surgery. 7. female patients who are pregnant or planning to become pregnant.

Keywords: blood transfusion erythropoietin iron suppletion
histerectomy vs partial myometrial resection for placenta accreta spectrum

Conditions: Placenta Accreta

Summary: currently, placenta accreta spectrum (pas) has two treatment options: hysterectomy (completely removing the uterus) and partial myometrial resection (resecting the part of the uterus affected by this pathology). the present study is a feasibility study of a multicenter, randomized controlled clinical trial to be carried out in 3 health institutions. patients who meet the inclusion criteria, after signing the informed consent, will be taken to the surgical procedure and before the start of the procedure they will be randomized to one of the two interventions, hysterectomy or partial myometrial resection, intra-surgical clinical outcomes will be explored and a follow-up will be carried out during the immediate post-surgical period (72 hours), in 7 to 12 days and at 42 days postpartum. a sample size of 60 patients is estimated among the 3 health institutions, with an approximate duration of the study of 24 months.

placenta accreta spectrum is a serious condition associated with significant maternal morbidity and even mortality. the recommended treatment is hysterectomy. an alternative is 1-step conservative surgery, which involves the en bloc resection of the myometrium affected by placenta accreta spectrum along with the placenta, followed by uterine reconstruction. currently, there are no studies comparing the 2 techniques in the setting of a randomized controlled trial. we performed a prospectively registered multicenter randomized controlled trial comparing hysterectomy with 1-step conservative surgery. the aim was to collect feasibility and clinical outcomes of the 2 techniques in women assigned to hysterectomy or 1step conservative surgery. in addition to assessing participants' willingness to be randomized, we also collected data on intraoperative blood loss, transfusion requirement, serious adverse event, and other clinical outcomes. sixty women with strong antenatal suspicion of placenta accreta spectrum were assigned randomly to either hysterectomy (n=31) or 1-step conservative surgery (n=29).

Eligibility criteria:
inclusion criteria: * pregnant women over 18 years of age. * history of previous cesarean section and anterior placenta previa * patients with prenatal diagnosis by ultrasound or mri of pas, regardless of the suspected degree of severity of the disease. * requirement for surgical management of placental accreta on a scheduled basis. * patients without active vaginal bleeding in the period immediately before surgery (patients entering the operating room without active bleeding). exclusion criteria: * women without previous living children.

Keywords: placenta accreta resective reconstructive treatment hysterectomy
substance abuse pre-treatment screening study

Conditions: Cocaine Abuse; Cocaine Dependence; Opiate Dependence; Alcohol Dependence; Substance Abuse

Summary: the overarching goal of this project is to have a consolidated consent and evaluation procedure that will lead potential subjects to the most appropriate clinical trial or human laboratory study (and its consent process) for their presenting concerns or interests. a second purpose is to have a consolidated intake data base on which secondary analyses can be conducted.

approximately 1500 candidates per year will respond to advertisements and will complete preliminary telephone screening without identifiers. appropriate candidates will be given appointment times and on arrival will undergo the consent process for evaluation. a complete medical, social, psychiatric, and drug use history will be obtained. subjects fulfilling general health inclusion requirements will then be offered an appropriate study for which the specific consent will be obtained. the evaluation period will be no more than one day with all results evaluated within the two following days. acceptable candidates will then be invited to complete the study specific consent.

Eligibility criteria:
inclusion criteria: * willing and able to participate in 3- to 6-month treatment program. * at least 18 years of age. * seeking treatment for substances of abuse including (cocaine, opiates, and alcohol). * generally physically healthy. exclusion criteria: * pregnant or breastfeeding. * mandated by the courts/parole officers to attend treatment. * not seeking treatment for substances of abuse. * plans to move from the houston area within the 3- to 6-month treatment period. * seeking treatment for a substance for which the treatment research clinic (trc) has no current trial.

Keywords: substance abuse treatment eligibility
genetics of primary ciliary dyskinesia

Conditions: Primary Ciliary Dyskinesia; Kartagener Syndrome

Summary: this study is designed to study dna sequencings for mutations in a research genetic test panel of genes (which contains all 32 known and/or published genes associated with pcd). the study aims to show that about 70% of pcd patients have biallelic mutations in one of these genes. this project will enroll patients who have already had a clinical evaluation, and have clinical features consistent with pcd.

the investigators have established a consortium of 9 geographically-dispersed clinical research sites to study rare disease of the airways, including primary ciliary dyskinesia (pcd). pcd is a genetic disorder with defective mucociliary clearance (mcc), sinus and pulmonary disease with chronic infection, and organs located on the wrong side of the body in about 50% of patients (kartagener syndrome). lung disease occurs early in children with pcd, but establishing a diagnosis remains a major challenge, based on the traditional approaches of using electron microscopy and/or ciliary waveform analysis to define abnormalities of ciliary ultrastructure and/or function. for this study, blood or buccal samples for dna will be collected and genetic testing in patients with known or suspected pcd will be performed. this study can include term neonates with respiratory distress of unknown etiology and features of pcd, particular laterality defects (situs inversus or heterotaxy). the key hypothesis for this study is that a genetic test panel of 32 genes will confirm a diagnosis in most patients with pcd.

Eligibility criteria:
inclusion criteria: * any patient who has ≥ 2 clinical features (+/- lab) characteristic of pcd, including: * neonatal respiratory distress after term (or near-term) birth * and/or laterality defect ( situs inversus or heterotaxy) * and/or daily wet cough before 6 months of age * and/or middle ear disease * and/or chronic nasal congestion before 6 months of age * and/or bronchiectasis * and/or male infertility due to sperm tail dysfunction * and/or low nasal nitric oxide levels (\<77 nanoliters/minute) * and/or defective ciliary ultrastructure exclusion criteria: * known diagnosis of cystic fibrosis with classic clinical presentation and elevated sweat chloride levels and/or two known disease-causing cystic fibrosis transmembrane conductance regulator (cftr) mutations, or documented primary or acquired immunodeficiency. * known explanation for bronchiectasis (and other clinical features), such as α1-antitrypsin deficiency (zz or zs), inflammatory bowel disease or rheumatoid arthritis. * any patient who is unwilling or unable to provide consent or to comply with the testing required in this protocol a participant should not be in the study if they have not had a standard clinical evaluation to address other potential causes of chronic oto-sino- pulmonary disease.

Keywords: primary ciliary dyskinesia kartagener syndrome
human photoallergy test

Conditions: Sunscreening Agents

Summary: to evaluate the potential of a test material to produce a photo allergic response.


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (fitzpatrick skin type i, ii, iii); * have read and signed the written informed consent form and have completed a health insurance portability and accountability act (hipaa) authorization form in conformance with 45cfr parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator; exclusion criteria: * have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; * have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products; * subjects who are employees of the cro and/or bayer or is a household member of an employee;
response predictors of theta-burst stimulation for depression

Conditions: Depression

Summary: the study consists of an open label trial designed to treat adult depression with tbs. our aim is to build capacity in neuroimaging analyses by performing magnetic resonance imaging (mri) assessments at baseline and after 7-10 days of treatment onset in 70 patients. the scientific goal is to test a hypothesis about treatment action: that tbs will reduce negative bias (which causally maintains negative mood) after 1 week of treatment, and patients who show this neurocognitive change will be the ones who go on to respond clinically after 6 weeks.

depressive disorders are among the leading causes of incapacity and disability worldwide. the burden of depression is expected to increase and is associated with negative impact on clinical conditions and physical and cognitive abilities. given the limited efficacy of antidepressant drugs, novel treatments such as theta-burst brain stimulation (tbs), a form of repetitive transcranial magnetic stimulation (rtms), are being developed. however, to further advance the field towards treatment personalisation, increasing understanding of tbs antidepressant mechanisms and identifying treatment responders are important issues. moreover, no studies have used neuroimaging in tbs trials in depression yet. our group in brazil is a leading brain stimulation centre, although neuroimaging expertise is lacking. we will conduct an open label trial designed to treat adult depression with tbs. our aim is to build capacity in neuroimaging analyses by performing magnetic resonance imaging (mri) assessments at baseline and after 7-10 days of treatment onset in 70 patients. the scientific goal is to test a hypothesis about treatment action: that tbs will reduce negative bias (which causally maintains negative mood) after 1 week of treatment, and patients who show this neurocognitive change will be the ones who go on to respond clinically after 6 weeks. scientifically, this proposal and its outcomes will help advance towards next-generation precision brain stimulation, by incorporating cognitive/neuroimaging readouts that inform about mechanism and individual response.

Eligibility criteria:
inclusion criteria: participants aged from 18 to 65 years, with hdrs score ≥ 14, with mdd confirmed by mini structured interview. - exclusion criteria: other mental disorders (alcohol or other substance dependence, bipolar disorder, psychotic disorders or dementia), severe clinical or neurological disorders, suicidal ideation, presence of psychotic symptoms, severe depression characterized by hdrs score \> 28, manic symptoms characterized by score \> 8 in the young mania rating scale. in addition, patients with specific contraindications to magnetic stimulation or magnetic resonance imaging will be excluded, such as having any metallic implants, epilepsy or any electronic component in the head.

Keywords: depression tbs fmri response predictors
labor induction and maternal bmi, comparison of different pre-induction cervical ripening methods

Conditions: Obesity; Labor Complications

Summary: the purpose of this study is to investigate whether mechanical cervical ripening (using the cook double balloon catheter) is superior or inferior to pharmacological agents (pge1) in overweight and obese women undergoing labor induction.


Eligibility criteria:
inclusion criteria: * age 18 years of age or older. * diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication for labor induction, including: postdate pregnancy, preeclampsia, gestational or chronic hypertension, gestational diabetes mellitus at term, oligohydramnios, polyhydramnios, fetal growth restriction, maternal background disease necessitating delivery, isoimmunisation, maternal thrombophilia, intrahepatic cholestasis of pregnancy. * having a bishop score of 4 points or less. * diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex presentation, with intact membranes, and absence of significant regular uterine contraction. * willingness to comply with the protocol for the duration of the study. * has agreed and signed an informed consent after given oral and written explanation. exclusion criteria: * anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation, estimated fetal weight of less than 4500 gr). * ruptured membranes. * previous cesarian section or presence of any uterine scar. * documented labor with four or more spontanous uterine contractions per hour. * suspected fetal distress necessitating immediate intervention. * proven malignancy of the cervix. * active vaginal bleeding. * active inflammatory or purulent condition of the lower genital tract. * active asthma.

Keywords: obesity labor complications induction of labor mechanical cervical ripening
intravenous fluids versus naso/orogastric-tube feeding in hospitalized infants with bronchiolitis

Conditions: Viral Bronchiolitis

Summary: oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (iv) fluids in hospitalized infants with acute viral bronchiolitis.


Eligibility criteria:
inclusion criteria: * infants with bronchiolitis \< 6 months who need to be hospitalized and are not able to eat per os. exclusion criteria: * infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an informed consent.